Our experience shows that the success or failure of a qualification project frequently depends on the interfaces between the contractor, the client and the supplier. The project organization must be adapted to the complexity of the qualification project. The qualification coordinator thereby plays a central role in complex projects. He coordinates all of the parties involved and ensures not only good communication but also compliance with the schedule. The qualification process for subsystems, package units, analysis systems, clean rooms and all other systems must be defined very early. It is important differentiate between start-up/initial commissioning tests (Good Engineer[1]ing Practice [GEP]) and qualification tests relevant to GMP. If at the beginning of the project the qualification strategy is explained to the suppliers, or if the suppliers have influence on this strategy, a high level of efficiency can be achieved. Qualification-relevant tests can be carried out by the suppliers as part of factory acceptance tests (FATs). If the supplier is familiar with the quality requirements of the customer and complies with specified acceptance criteria, time-consuming repeat tests at the future operator’s site can be omitted. Qualification can be completed faster and production started more quickly.
The respective partners must be thoroughly familiar with their roles to facilitate this. It is often the case that certain functions can only be tested when different units are working together across respective supplier boundaries. Further coordination is required at these interfaces. For example, the function of a cleaning-in-place (CIP) system can only be qualified when the installation and start-up of the systems to be cleaned and the supporting media systems have been completed and the process control system has been installed.
Change management is another essential component of an efficient qualification strategy. Handling changes and the corresponding administrative work involved tie up resources, which are then no longer available for other tasks, leading to possible delays in the project. The participating departments (quality assurance, production and qualification coordination) must define how changes are to be handled at the start of the project.
Efficient qualification strategies require matching project organization, which Chemgineering tailors to the respective customer requirements. Thus, we meet the requirements of global players as well as those of small and mid-sized pharmaceutical companies.